Safety Study of Ragweed-SPIRE in Subjects With Ragweed Allergies and Asthma

Asthma Clinical Trial

Official title:

A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Parallel-Group Study to Assess the Safety and Tolerability of Ragweed-SPIRE in Subjects With Asthma and Ragweed-Induced Rhinoconjunctivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02061670
• Other study ID #: TR007
• Status: Completed
• Phase: Phase 2
• First received: February 3, 2014
• Last updated: January 20, 2015
• Start date: January 2014
• Est. completion date: October 2014

Study information

• Verified date: January 2015
• Source: Circassia Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether it is safe to administer Ragweed-SPIRE to subjects suffering from both ragweed allergy and asthma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female, aged 18-65 years.

• Asthma treated by inhaled SABA or inhaled SABA plus low-medium dose ICS in 6 weeks prior to randomisation.

• A reliable history consistent with moderate to severe rhinoconjunctivitis on exposure to ragweed for at least the previous two ragweed seasons.

• Positive skin prick test to ragweed

• Ragweed-specific Immunoglobulin E (IgE) = 0.35 kU/L.

Exclusion Criteria:

• History of life-threatening asthma.

• Uncontrolled asthma according to GINA

• FEV1 of < 70 % of predicted, regardless of the cause.

• Administration of adrenaline (epinephrine) is contraindicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).

• History of severe drug allergy or anaphylactic reaction to food.

• A history of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Biological:
• Ragweed-SPIRE
Intradermal injection
• Placebo

Locations

Country	Name	City	State
Canada	Kanata Allergy Services	Kanata	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	Cheema Research Inc	Mississauga	Ontario
Canada	Ottawa Allergy Research Corp	Ottawa	Ontario
Canada	Inflamax Research	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Circassia Limited	Adiga Life Sciences, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events as a measure of safety and tolerability		Throughout subjects participation in the study, approximately 22 weeks	Yes
Secondary	Number of subjects with asthma exacerbations as a measure of safety and tolerability		Throughout subjects participation in the study, approximately 22 weeks	Yes
Secondary	Evaluation of change in lung function as a measure of safety and tolerability		Throughout subjects participation in the study, approximately 22 weeks	Yes